Status:
TERMINATED
Assess the Safety and Effectiveness of Once Daily PMR Compared to Twice Daily Pletaal® in Patients With Intermittent Claudication
Lead Sponsor:
Genovate Biotechnology Co., Ltd.,
Conditions:
Intermittent Claudication
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
The study is designed to compare the efficacy and safety of once daily PMR treatment with twice daily Pletaal® treatment in patients with intermittent claudication caused by peripheral arterial diseas...
Eligibility Criteria
Inclusion
- Main
- Stable use of Cilostazol of any strength and any dosing frequency for at least 3 months prior to screening, for the treatment of peripheral arterial disease.
- Initial claudication distance ≥ 30 meters at the constant workload treadmill test.
- Main
Exclusion
- Presence of limb-threatening chronic limb ischemia, manifested by ischemic rest pain, ulceration or gangrene.
- History of lower-extremity surgical or endovascular arterial reconstructions or sympathectomy within 3 months prior to screening.
- Presence of illness(es) (such as angina pectoris, respiratory disease, orthopaedic disease, or neurological disorders, except the study disease) limiting the exercise capacity.
- Presence of uncontrolled hypertension (based on physician's judgment) or other unstable cardiovascular disease such as congestive heart failure of any severity and myocardial infarction within 6 months prior to screening.
- History of coronary artery bypass graft (CABG) or major cardiovascular surgical procedures within 6 months prior to screening.
- History of Buerger's disease or deep vein thrombosis within 3 months prior to screening.
- Presence of haemostatic disorders or active pathologic bleeding, such as bleeding peptic ulcer and intracranial bleeding.
- Presence or history of ventricular tachycardia, ventricular fibrillation or multifocal ventricular tachycardia with or without adequate treatment, QTc prolongation associated with cardiac disorders, or severe tachyarrhythmia within 6 months prior to screening, which is considered not suitable for this study by Investigator.
- History of type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus.
- Use of anticoagulant agent(s) within 6 months prior to screening.
- Use of two or more than two anti-platelet agents within 3 months prior to screening.
Key Trial Info
Start Date :
March 14 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 8 2017
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT06886620
Start Date
March 14 2016
End Date
February 8 2017
Last Update
March 20 2025
Active Locations (5)
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1
National Taiwan University Hospital
Taipei, Taiwan, 10016
2
Mackay Memorial Hospital
Taipei, Taiwan, 10449
3
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
4
Cheng Hsin General Hospital
Taipei, Taiwan, 112